Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA.
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital and Research Institute, Seattle, WA, USA.
Genet Med. 2019 Jan;21(1):107-113. doi: 10.1038/s41436-018-0032-6. Epub 2018 Jun 11.
To determine whether patients distinguish between biospecimens and electronic health records (EHRs) when considering research participation to inform research protections.
We conducted 20 focus groups with individuals who identified as African American, Hispanic, Chinese, South Asian, and non-Hispanic white on the collection of biospecimens and EHR data for research.
Our study found that many participants did not distinguish between biospecimens and EHR data. However, some participants identified specific concerns about biospecimens. These included the need for special care and respect for biospecimens due to enduring connections between the body and identity; the potential for unacceptable future research, specifically the prospect of human cloning; heightened privacy risks; and the potential for unjust corporate profiteering. Among those who distinguished biospecimens from EHR data, many supported separate consent processes and would limit their own participation to EHR data.
Considering that the potential misuse of EHR data is as great as, if not greater than, for biospecimens, more research is needed to understand how attitudes differ between biospecimens and EHR data across diverse populations. Such research should explore mechanisms beyond consent that can address diverse values, perspectives, and misconceptions about sources of patient information to build trust in research relationships.
为了确定在考虑参与研究时，患者是否会区分生物样本和电子健康记录（EHR），从而为研究保护提供信息。
我们对 20 个不同群体的参与者进行了焦点小组讨论，这些参与者在收集生物样本和 EHR 数据用于研究时，自我认同为非裔美国人、西班牙裔、华裔、南亚裔和非西班牙裔白人。
我们的研究发现，许多参与者并不区分生物样本和 EHR 数据。然而，一些参与者对生物样本有特定的担忧。这些担忧包括：由于身体和身份之间的持久联系，需要对生物样本给予特殊的护理和尊重；未来不可接受的研究的可能性，特别是人类克隆的前景；隐私风险增加；以及企业不当获利的潜在风险。在那些将生物样本与 EHR 数据区分开来的参与者中，许多人支持单独的同意程序，并将自己的参与限制在 EHR 数据上。
考虑到 EHR 数据的潜在滥用与生物样本一样大，如果不是更大的话，那么需要更多的研究来了解不同人群对生物样本和 EHR 数据的态度差异。这种研究应该探索超越同意的机制，以解决关于患者信息来源的不同价值观、观点和误解，从而建立对研究关系的信任。
